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1. 20uL 10 0 2ng mL 0 26ng mL 4 HH 1865 CEA 150 GOOkDa2. 1 b CEA CEA CEA 1 CEA CEA
3. 5 1 1 2 5 CEA 5 25ng mL 1ng mL 547ng mL 42ng mL 1 00 3 0ng mL 0 0 5 0ng mL n 347 138 149 CEA ng mL n 0 0 3 0 3 1 5 0 _5 1 10 0 gt 10 0 188 180 96 0 8 40 0 OO0 0 OO0 149 113 75 8 31 208 5 324 0 00 347 303 872 39 11 2 5 12 0
4. H CEA SB0nm 612nm CEA LOCI Luminescent Oxygen Channeling Immunoass 1 ay 3
5. RS 2 80 i A LD HI HBV HCV Ma 8C 12 1 2 0 6 0 1 18 19 20 21 22 23 Ullman EF Kirakossian H Switchenko AC Ishkanian J et al Luminescent oxygen channelind assay LOCIW sensitive broadly applicable homogenous immun0assay method Cl
6. 14 1 0 8 974ng mL ng mL n vs 1 00 1 45 0 987 5 vs 0 99 2 55 0 998 54 f CEA 1 2 8992 6ng mL CEA 3 4ng mL CEA 5 15 28 MD Ma i CEA a a CEA X 100 CEA 157 5 751 5ng mL 5 1 1 3 1 4 1 5 1 10 CEA 98 1099 6 102 996 LoD 0 2ng mL CLSI EP17 A23 4
7. 4 C 7 80 4 15 000Xg 10 CLSINCCLS EP7 A 9 109 CEA ng mL 9 1000mg dL 5 lt 10 500 10
8. CV 109 0 2 1000 0ng mL 3 9 ng mL i Liquicheck Immunoassay Plus Control 1 1 0 1 2 9 0 1 3 4 6 0 6 2 2 0 8 2 9 1 0 9 0 02 2 3 0 08 2 6 12 8 0 3 2 6 0 4 3 1 3 67 5 1 3 1 9 1 6 2 4 4 478 6 2 1 3 10 0 2 1 5 756 4 13 6 1 8 4 9 3 3 39 7 5 2 2 8 8 6 3 6 LiquicheckW Bio Rad Laboratories C CLSI NCCLS EP5 A 1 20 ee ng mL n CLIA 1 01 8 01 0 989 141 d CLSI NCCLS EPB A
9. CEA 5ng mL 1096 CEA NCA 500ng mL NCA 2 100ng mL 3 1 LOCI5 V KC600 LOCI6 V KC604 3 1 GOuL GOuL GuL 100uL 37 0C 10 BB0nm 6 12nm 4
10. a CEA CEA i i lt 3 1000ng mL 10
11. 60mg dL 5 10 500 lt 10 60mg dL 5 lt 10 500 Intralipid 3000mg dL 5 lt TQ 500 lt 10 Intralipide Fresenius Kabi AG CEA 1 3 541ng mL 1096 0mg dL 5 3mg dL 8mg dL 6mg dL 125mg dL G lgG 5g dL 12ug dL 100mg dL 3 3mg dL 1 2mg dL 6mg dL mg dL 3mg dL 450 5mg dL 90 1mg dL 0 1mg dL
12. 3 4 CEA 596 CEA CEA 9 9 1 1 KC ma Col CEA Ong mL 1000ng mL Ong mL 2385 1096
13. K6453 REP a et 82012 10 2 52 1 00AMX08278000 SIEMEINS CEA V 1 4 CEA 5 8 CEA 9 12
14. 1 1 F DL 111 271GC 2011 06 07 B PN781453 001
15. 291 CEA CEA n 9 n 96 n 9 n 9 36 2 6 28 14 6 5 6 28 32 14 8 58 26 7 12 5 5 33 15 2 62 28 6 282 10 1 1129 59 5 36 0 5 3 15 69 6 8 4 8 30 38 23 10 6 62 28 6 74 34 1 58 26 2 217 100 0 NED RCV 36 296 32 26 58 36 296 26 133 159 58 159 817 9596 9 76 0 69 8 81 6 9 6 55 2 41 5 68 3
16. 5mg dL 50mg dL 1mg dL 10mg dL 4 0 6mg dL G 25U mL 500mg dL 8mg dL mg dL 10mg dL 30mg dL 5mg dL 360 4mg dL 4mg dL 40 6g dL 0 16mg dL 0 51mg dL 6g dL 6 1ng mL 8g dL 16 5mg dL 500IU mL 6mg dL 60mg dL 400mg dL 6mg dL 5mg dL 4mg dL 5 130 9mg dL 3060mg dL 6 5mg dL 500mg dL 6mg dL 0mg dL 1mg dL 50mg dL g L 4mg dL 3U mL 0 44mg dL 50mg dL CEA
17. 83 6 77 0 89 0 RCV 36 796 32 32 64 36 796 26 127 153 58 159 817 9596 73 3 66 9 79 0 55 2 41 5 68 3 79 9 72 8 85 8 9 1 959 9596 CI 959 CI 1 2416 1 5827 9596 CI 1 2180 1 4771 9 RCV 2
18. 2 3 C 4 LOCI 5 V 1 A 0 B 5 3 C 100 4 D 500 5 E 1050 ng mL E A ng mL 5 3 30
19. CEA 75 1 74 3 G9 1 reference change value RCV CEA 6 HCV CEA HCV 36 296 RCV 36 796 CEA 1 RCV NED 74 1 7
20. Davison AC Hinkley DV Bootstrap methods and their application Cambridge NY Cambridge University Press 1997 Ryall RG Story CJ and Turner DR Reappraisal of the causes of the hook effect in two site immunoradiometric assays Anal Biochem 1982 127 308 315 Kricka LJ Human Anti Animal Antibody Interferences in Immunological Assays Clin Chem 1999 45 7 942 956 Vaidya HC Beatty BG Eliminating interference from heterophilic antibodies in a two site immunoassay for creatine kinase MB by using F ab 2 conjugate and polymouse lgG Clin Chem 1992 38 1737 1742 Gold P Freedman S0 Demonstration of Tumor Specific Antigens in Human Colonic Carcinomata by Immunological Tolerance and Absorption Techniques J Exp Med 1965 121 439 462 Chan DW Booth RA Diamandis EP Tumor Markers in Tietz Textbook of Clinical Chemistry and Molecular Diagnostics Fourth Edition 2006 768 769 Paus E Almasbak H et al A Single chain Fv based Immunoflurometric Assay Specific for the CEA Variant NCA 2 J Immuunol Methods 2003 286 125 139 Tietz Clinical Guide to Laboratory Tests Fourth Edition 2006 220 222 NACB Practice Guidelines And Recommendations For Use Of Tumor Markers In The Clinic Quality Requirements Section 2 National Academy of Clinical Biochemistry Guidelines on Quality Requirements for the Use of Tumor Markers Catharine Sturgeon Elizabeth Hammond Soo Ling Ch ng GyOrgy SOI6tormos Daniel F Hayes Perkins GL Slater ED et al Serum
21. 0 4 15 o 5 596 LoB 0 12ng mL 1 0 HIV HBV HCV Di Pe 5 2 2gH 3 i 3 3 1
22. 45 55 CEA 5 314 CEA CEA 9 CEA CEA
23. Tumor Markers Am Family Physician 2003 68 1075 1082 Goldstein MJ Mitchell EP Carcinoembryonic Antigen in the Staging and Follow up of Patients wi Colorectal Cancer Cancer Invest 2005 23 338 351 Fakih MG CEA Monitoring in Colorectal Cancer Oncology 2006 20 Clinical and Laboratory Standards Institute NCCLS Evaluation of Precision Performance 0 Quantitative Measurement Methods Approved Guideline Second Edition CLSINCCLS document EP5 A2 ISBN1 56238 542 9 CLSI 940 West Valley Road Suite 1400 Wayne PA 19087 1898 USA 2004 Clinical and Laboratory Standards Institute NCCLS Method Comparison and Bias Estimation Using Patient Samples Approved Guideline Second Edition CLSI NCCLS document EP9 A2 ISBN 1 56238 472 4 CLSI 940 West Valley Road Suite 1400 Wayne PA 19087 1898 USA 2002 Clinical and Laboratory Standards Institute NCCLS Protocols for Determination of Limits of Detection and Limits of Quantitation Approved Guideline CLSINCCLS document EP17 A ISBN 1 56238 551 8 CLSI 940 West Valley Road Suite 1400 Wayne PA 19087 1898 USA 2004 TEL 03 3493 8400
24. OO 74 48 64 9 6 8 1 7 94 13 7 6 74 2 36 79 6 36 796 36 296 55 3 58 36 296 9 150 59 64 153 17 9596 6 9g4 5 205 17 90 5 87 1 9 85 9 55 624 75 0 93 4 9 98 0 150 153 94 4 99 6 9 25 000ng mL
25. in Chem 42 9 1996 1518 1526 Ullman EF Kirakossian H Sharat S Ping Wu Z Irvin BR et al Luminescent oxygen channeling immun0assay Measurement of particle binding kinetics by chemiluminescence Proc Natl Acad Sci USA Vol 91 pp 5426 5430 June 1994 Biochemisty Clinical and Laboratory Standards Institute NCCLS Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture ADproved Standard FifIh Edition CLSINCCLS document H3 A5 ISBN1 56238 515 11 CLSI 940 West Valley Road Suite 1400 Wayne PA 19087 1898 USA 2003 Young DS Effects of Preanalylical Variables on Clinical Laboratory Tests Second Edition AACC Press Washington DC 1997 Clinical and Laboratory Standards Institute NCCLS Interference Testing in Clinical Chemistry Approved Guideline Second Edilion CLSI INCCLS document EP7 A2 ISBN 1 56238 584 4 CLSI 940 West Valley Road Suite 1400 Wayne PA 19087 1898 USA 2005 Fraser Callum G PhD Biological Variation From Principles to Practice Washington DC AACC Press 2001 pp 71 78 Ricos C Alvarez V Cava F Garcia Lario JV Hernandez A Jimenez CV Minchinela J Perich C Simon M Current databases on biologic variation pros cons and progress Scand J Clin Lab Invest 1999 59 491 500 lt http www westgard com biodatabase1 htmls B Emir S Wieand John Q S and S Cha Analysis of repeated markers used to predict progression of cancer Statistics In Medicine 1998 2563 2578
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